Mr. Matheson
introduced the following bill; which was referred to the
Committee on Energy and
Commerce

A BILL

To amend the Public Health Service Act to enhance efforts
to address antimicrobial resistance, and for other purposes.

1.

Short title

This Act may be cited as the
Strategies to Address Antimicrobial
Resistance Act.

2.

Findings

The Congress finds as follows:

(1)

The advent of the
antibiotic era has saved millions of lives and allowed for incredible medical
progress; however, the increased use and overuse of antimicrobial drugs have
correlated with increased rates of antimicrobial resistance.

(2)

Through mutation
as well as other mechanisms, bacteria and other infectious disease-causing
organisms—viruses, fungi, and parasites—develop resistance to antimicrobial
drugs over time. The more antimicrobial drugs are used, whether appropriately
or inappropriately, the more this contributes to the development of
antimicrobial resistance.

(3)

Scientific
evidence suggests that the development of antimicrobial resistance in humans is
not due only to use of antimicrobial drugs in humans, but also may be caused by
the use of antimicrobial drugs in food-producing animals.

(4)

A
study estimates that in 2005 more than 94,000 invasive methicillin-resistant
Staphylococcus aureus (MRSA) bacterial infections occurred in the United States
and more than 18,500 of these infections resulted in death—7 times more than a
decade earlier.

(5)

The 2009 Influenza
A: H1N1 virus outbreak, and the yearly seasonal influenza outbreaks, exacerbate
concerns about antiviral resistance given that so few antivirals are available
to treat influenza as well as secondary bacterial infections due to MRSA,
antibiotic-resistant Streptococcus pneumonia, and other bacteria that cause
respiratory diseases. Given that, during the 1918 influenza pandemic, many
thousands of deaths were caused by complications due to secondary bacterial
infections and not by the influenza virus itself.

(6)

Each year, nearly
2,000,000 people contract bacterial infections in hospitals and approximately
90,000 of these people die from these infections. Many of these infections are
resistant to one or more commonly used antibiotics.

(7)

A
2012 study conducted at Columbia University (Clinical Infectious
Disease, September 2012) found that each antibiotic-resistant infection
cost, on average, over $15,000 more to treat than susceptible
infections.

(8)

The costs of
antimicrobial-resistant infections in terms of lives lost and the economy will
only rise as antimicrobial resistance continues to spread.

in the subsection
heading, by striking Task
Force and inserting the following:
Antimicrobial Resistance
Office, Task Force, and Advisory Board;

(B)

in paragraph
(1)—

(i)

by
striking as of the date of the enactment of this section and
inserting as of September 30, 2006; and

(ii)

by
adding at the end the following: The Secretary shall, not later than 1
year after the date of enactment of the Strategies to Address Antimicrobial
Resistance Act, direct the Assistant Secretary of Health to establish an
Antimicrobial Resistance Office and appoint a director to that Office. The
Secretary shall, not later than 1 year after the date of enactment of such Act,
establish the Public Health Antimicrobial Advisory Board as an advisory board
to the Director of the Antimicrobial Resistance Office. The Director of the
Antimicrobial Resistance Office shall serve as the Director of the
Antimicrobial Resistance Task Force. To avoid duplication and ensure that
Federal resources are used efficiently and effectively, the Director shall work
in conjunction with the Federal agencies represented on the Task Force to
coordinate all antimicrobial resistance activities undertaken and supported by
the Federal Government, including the activities and budgetary allocations of
the Office, Task Force, and Public Health Antimicrobial Advisory
Board.;

(C)

by amending
paragraph (2) to read as follows:

(2)

Members

(A)

Members of the
antimicrobial resistance task force

The task force described in
paragraph (1) shall be composed of representatives of such Federal agencies as
the Secretary determines necessary, including representation of the
following:

(i)

The Antimicrobial
Resistance Office.

(ii)

The Assistant
Secretary for Preparedness and Response.

(iii)

The Biomedical
Advanced Research and Development Authority.

(iv)

The Centers for
Disease Control and Prevention.

(v)

The Food and Drug
Administration.

(vi)

The National
Institutes of Health.

(vii)

The Agency for
Healthcare Research and Quality.

(viii)

The Centers for
Medicare Medicaid Services.

(ix)

The Health
Resources and Services Administration.

(x)

The Department of
Agriculture.

(xi)

The Department of
Education.

(xii)

The Department
of Defense.

(xiii)

The Department
of Veterans Affairs.

(xiv)

The
Environmental Protection Agency.

(xv)

The Department of
Homeland Security.

(xvi)

The United States Agency for International
Development.

(B)

Members of the
public health antimicrobial advisory board

(i)

In
general

The Public Health Antimicrobial Advisory Board shall be
composed of 19 voting members, appointed by the Secretary. Such members shall
include experts from the medical professions (including hospital and
community-based physicians), pharmacy, public health, veterinary, research, and
international health communities, as well as one representative from a public
interest group.

(ii)

Terms

Each
member appointed under clause (i) shall be appointed for a term of 3 years,
except that of the 19 members first appointed—

(I)

6 shall be
appointed for a term of 12 months; and

(II)

6 shall be
appointed for a term of 2 years.

(iii)

Chair

The
Secretary shall appoint a Chair of the Public Health Antimicrobial Advisory
Board from among its members to lead and supervise the activities of the
Advisory Board.

(iv)

Disclosure of
financial interests

Prior to a meeting of the Public Health
Antimicrobial Advisory Board, each member of the Advisory Board shall disclose
to the Secretary any potential, relevant financial interests as defined under
section 208(a) of title 18, United States
Code.

;

(D)

in paragraph
(3)(B), by striking in consultation with the task force described in
paragraph (1) and and inserting acting through the Director of
the Antimicrobial Resistance Office and the Director of the Centers for Disease
Control and Prevention, and in consultation with; and

(E)

by amending
paragraph (4) to read as follows:

(4)

Meetings and
duties

(A)

Antimicrobial
resistance office duties

The Director of the Antimicrobial
Resistance Office, working in conjunction with the Federal agencies that are
represented on the task force described in paragraph (1), shall issue an update
to the Public Health Action Plan to Combat Antimicrobial Resistance within 1
year of the establishment of the Office and annually thereafter. The updates
shall include enhanced plans for addressing antimicrobial resistance in the
United States and internationally. The Director of the Office shall post on a
website these updates as well as summaries of all non-proprietary data the Task
Force makes available. The Director of the Antimicrobial Resistance Office
shall work in conjunction with the Federal agencies that are represented on the
task force described in paragraph (1), and in consultation with the Public
Health Antimicrobial Advisory Board, to—

(i)

establish
benchmarks for achieving the goals set forth in the action plan;

(ii)

assess the
ongoing, observed patterns of emergence of antimicrobial resistance, and their
impact on clinical outcomes in terms of how patients feel, function, or
survive;

(iii)

assess how
antimicrobial products are being used in humans, animals, plants, and the
environment and the risks and benefits of those uses in furthering the
development of resistance and the implications thereof for patient safety and
public health;

(iv)

establish a
priority list of human infectious diseases with the greatest need for
development of new point-of-care and other diagnostics, antimicrobial drugs,
and vaccines, and in particular serious and life-threatening resistant
infections, for which there are few or no diagnostic, treatment, or prevention
options;

(v)

recommend basic,
clinical, epidemiological, prevention, and translational research where
additional federally supported studies may be beneficial;

(vi)

recommend how to
support antimicrobial development through Food and Drug Administration
activities, including through the agency’s Critical Path Initiative and the
Reagan-Udall Foundation;

(vii)

recommend how
best to strengthen and link antimicrobial resistance-related surveillance and
prevention and control activities; and

(viii)

collaborate
with the Assistant Secretary for Preparedness and Response to ensure that
strategies to address antimicrobial-resistance are coordinated with initiatives
aimed at pandemic influenza, severe acute respiratory syndrome, and
bioterrorism.

(B)

Antimicrobial
resistance task force meetings and duties

(i)

Meetings

The
Antimicrobial Resistance Task Force shall convene periodically as the Director
of the Antimicrobial Resistance Task Force determines to be appropriate, but
not fewer than twice a year, to consider issues relating to antimicrobial
resistance.

(ii)

Public health
action plan

At least twice a year, the task force described in
paragraph (1) shall have a meeting to review, discuss, and further develop the
Public Health Action Plan to Combat Antimicrobial Resistance first issued by
the interagency task force on antimicrobial resistance in 2001. Among other
issues, the task force may discuss and review, based on current need or
concern—

data obtained by
government agencies and, as possible, by private sources on emerging
antimicrobial resistance related to clinical outcomes as well as data related
to how antimicrobial drugs may have been used inappropriately;

(III)

surveillance
data and prevention and control activities regarding emerging antimicrobial
resistance from reliable sources including the Centers for Disease Control and
Prevention, the Food and Drug Administration, the Department of Defense, the
Department of Veterans Affairs, the Department of Agriculture, the
Environmental Protection Agency, and as feasible from private sources and
international bodies;

(IV)

data on the
amount of antimicrobial products used in humans, animals, plants, and the
environment from reliable sources, including data from the Centers for Disease
Control and Prevention, the Food and Drug Administration, the Environmental
Protection Agency, the Department of Veterans Affairs, the Centers for Medicare
Medicaid Services, the Department of Homeland Security, and the
Department of Agriculture, and as feasible from private sources and
international bodies;

(V)

the impact of
antimicrobial resistance on human health resulting from the approval of
antimicrobial drugs for use in humans, animals, or plants (including
consideration of and recommendations on potential management plans to limit and
reduce the negative impacts of such resistance on human health and
consideration of the benefits to animal health and food safety);

(VI)

reports of federally supported
antimicrobial resistance research and antimicrobial drug, related diagnostics,
and vaccine development for antimicrobial resistant infections (such as
methicillin-resistant Staphylococcus aureus (MRSA)) and other research
activities (including clinical, epidemiological, prevention, and
trans­la­tion­al research) obtained from Federal agencies, as well as reports
of research sponsored by other countries, industry, and non-governmental
organizations;

(VII)

reports on
efforts by the Food and Drug Administration to develop policies and guidance
which encourage antimicrobial drug, related diagnostics, and vaccine
development and appropriate use while maintaining high standards for safety and
effectiveness;

(VIII)

quality
measures, which may include health plan employer data and information set
(HEDIS) measures, pertaining to appropriate use of antimicrobial drugs;
and

(IX)

other data and
issues the task force described in paragraph (1) identifies as relevant to the
issue of antimicrobial resistance.

(iii)

Pending
applications

The Food and Drug Administration may consult with
the Director of the Antimicrobial Resistance Office concerning the pending
application of any antimicrobial drug application submitted to the Secretary
under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or the
Public Health Service Act.

(C)

Public health
antimicrobial advisory board meetings and duties

(i)

Meetings

The
Public Health Antimicrobial Advisory Board shall meet as the Chair of the
Public Health Antimicrobial Advisory Board determines to be appropriate,
preferably in conjunction with meetings of the Antimicrobial Resistance Task
Force, but not fewer than 2 times each year.

(ii)

Recommendations

The
Public Health Antimicrobial Advisory Board shall make recommendations to the
Secretary, and the Antimicrobial Resistance Office, regarding—

(I)

ways to encourage
the availability of an adequate supply of safe and effective antimicrobial
products, related diagnostics, and vaccines;

(II)

research
priorities and other measures (such as antimicrobial drug resistance management
plans) to enhance the safety and efficacy of antimicrobial products;

(III)

how best to
implement and update the goals of the Public Health Action Plan to Combat
Antimicrobial Resistance;

(IV)

incentives
necessary to establish uniform mechanisms (which could include electronic
surveillance systems) and data sets for State and local reporting of
resistance;

(V)

the adequacy of
existing United States antimicrobial resistance and use surveillance;

(VI)

the development
of a national plan for the collection and analysis of isolates of resistant
pathogens, including establishing priorities as to which isolates should be
collected; and

(VII)

areas for
government, nongovernment, and international cooperation to strengthen
implementation of the Public Health Action Plan to Combat Antimicrobial
Resistance.

(D)

Availability of
information

The Antimicrobial Resistance Office shall ensure that
all information shall be made available to the public on the website described
in subparagraph (A) consistent with section 9 of the Strategies to Address
Antimicrobial Resistance
Act.

;

(2)

by amending
subsection (b) to read as follows:

(b)

Antimicrobial
resistance strategic research plan

The Secretary, acting through
the Director of the National Institutes of Health, working in consultation with
the Director of the Centers for Disease Control and Prevention, the Assistant
Secretary for Preparedness and Response, the Director of the Biomedical
Advanced Research and Development Authority, the Director of the Antimicrobial
Resistance Office, the Public Health Antimicrobial Advisory Board, and other
non-government experts, including representatives from professional societies
and the pharmaceutical, vaccine, and medical device industries, and other
Federal agencies shall develop a blue-ribbon antimicrobial resistance strategic
research plan that strengthens existing epidemiological, interventional,
clinical, behavioral, translational, and basic research efforts to advance the
understanding of—

(1)

the development,
implementation, and efficacy of interventions to prevent and control the
emergence and transmission of antimicrobial resistance;

(2)

how best to
optimize antimicrobial effectiveness while limiting the emergence of
resistance, including addressing issues related to duration of therapy,
effectiveness of therapy in self-resolving diseases, and determining
populations most likely to benefit from antimicrobial drugs;

(3)

the extent to
which specific uses of antimicrobial products in humans, animals, plants, and
other uses accelerates development and transmission of antimicrobial
resistance;

(4)

the natural
histories of infectious diseases (including defining the disease, diagnosis,
severity, and the time course of illness);

(5)

the development of
new therapeutics, including antimicrobial drugs, biologics, and devices against
resistant pathogens, and in particular diseases for which few or no
therapeutics are in development;

(6)

the development
and testing of medical diagnostics to identify patients with infectious disease
and identify the exact cause of infectious diseases syndromes, particularly
with respect to the detection of pathogens resistant to antimicrobial
drugs;

(7)

the epidemiology,
pathogenesis, mechanisms, and genetics of antimicrobial resistance; and

(8)

the sequencing of
the genomes, or other DNA analysis, or other comparative analysis of priority
pathogens (as determined by the Public Health Antimicrobial Advisory Board), in
collaboration with the Department of Defense and the Joint Genome Institute of
the Department of
Energy.

;

(3)

in subsection
(c)—

(A)

by inserting
acting through the Director of the Antimicrobial Resistance
Office, after The Secretary,; and

(B)

by striking
members of the task force described in subsection (a),;

(4)

in subsection
(d)(1), by inserting , through the Antimicrobial Resistance
Office, after The Secretary;

(5)

in subsection
(e)—

(A)

by amending the
subsection heading to read as follows: Improving Uptake and Measurement of
Antimicrobial Stewardship;

(B)

in paragraph
(1)—

(i)

by
inserting , acting through the Director of the Antimicrobial Resistance
Office, after The Secretary; and

(ii)

by
striking judicious use of antimicrobial drugs or control the spread of
antimicrobial-resistant pathogens and inserting the uptake and
measurement of antimicrobial stewardship programs in the Nation’s health care
facilities;

(C)

in paragraph (2),
by striking laboratory;

(D)

in paragraph (3),
by inserting , acting through the Antimicrobial Resistance
Office, after The Secretary; and

(E)

by adding at the
end the following new paragraphs:

(4)

Definition of
antimicrobial stewardship

For purposes of this subsection and
Act, antimicrobial stewardship means coordinated interventions
designed to improve and measure the appropriate use of antimicrobial agents,
including promoting the use of antimicrobials only when clinically indicated,
and, when antimicrobials are indicated, promoting the selection of the optimal
antimicrobial drug regimen including dosing, duration of therapy, and route of
administration.

(5)

Preference in
making awards

In making awards under paragraph (1), the Secretary
shall give preference to eligible entities that will use grant funds to
establish demonstration projects that lead to the development of quality
measures for health care providers prescribing antimicrobial
drugs.

;

(6)

by redesignating
subsections (f) and (g) as subsections (i) and (j), respectively; and

(7)

by inserting after
subsection (e) the following new subsections:

(f)

Appropriate
antimicrobial use

The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall take such additional
actions as follows:

(1)

To pilot and test
health care quality measures to help providers, facilities, and health systems
measure and benchmark appropriate antimicrobial use. As appropriate, the
Director shall work with standard setting organizations (such as the National
Quality Forum, the Joint Commission, and the National Committee for Quality
Assurance) to determine if any such measure is suitable for national quality
reporting efforts.

(2)

To develop methods
to help providers, facilities, and health systems measure and improve
appropriate antimicrobial use, including methods and tools to assess the change
in antimicrobial use, the impact on antibiotic resistance and adverse effects
(such as Clostridium difficile infections), and the economic impact and cost
savings of antimicrobial stewardship programs.

The Director of the Centers for Disease Control and
Prevention shall work with private vendors, health care organizations, pharmacy
benefit managers, and other entities to obtain reliable and comparable human
antimicrobial drug consumption data (including volume antimicrobial
distribution data and antimicrobial use, including prescription data) by State
or metropolitan area.

(2)

Antimicrobial
Resistance Trend Data

The Director of the Centers for Disease
Control and Prevention shall intensify and expand their efforts to collect
antimicrobial resistance data including through the establishment of an
Antimicrobial Resistance Surveillance and Laboratory Network, established in
section 4 of the Strategies to Address Antimicrobial Resistance Act, and
development of a fully automated antimicrobial resistance and use module within
the National Healthcare Safety Network. The Director shall seek to collect data
from electronic medication administration reports (eMAR) and laboratory systems
to produce regular reports on antimicrobial resistance patterns and
antimicrobial use.

(3)

Meaningful Use
Reporting

The Office of the National Coordinator for Health
Information Technology shall work with the Director of the Centers for Disease
Control and Prevention to determine how best antimicrobial use, susceptibility,
and resistance data can be incorporated into meaningful use reporting.

(4)

Report

Not
later than 2 years after the date of the enactment of the Strategies to Address
Antimicrobial Resistance Act, and every two years thereafter, the Director of
the Centers for Disease Control and Prevention shall submit to the Committee on
Energy and Commerce of the House of Representatives and the Committee on
Health, Education, Labor and Pensions of the Senate and make available on the
agency’s website a report summarizing key trends and major issues related to
antimicrobial resistance and use in the United States. Each such report shall
include the most relevant and up-to-date data available from the infectious
diseases and surveillance programs of the Centers for Disease Control and
Prevention. Each such report shall—

(A)

outline major
issues and threats in antimicrobial resistance facing the United States;

(B)

provide data on
the incidence, prevalence, morbidity, mortality, and general societal burden,
including economic, of antimicrobial resistant pathogens;

(C)

provide updates on
resistance patterns and antimicrobials use data and potential impacts on human
health and patient safety;

(D)

articulate
activities of the Centers for Disease Control and Prevention targeted toward
measuring and preventing the spread of drug resistant pathogens;

(E)

describe any
international developments that may impact antimicrobial resistance in the
United States; and

(F)

identify the major
gaps that the Nation faces in the areas of antimicrobial resistance
surveillance, prevention, use, and antimicrobial stewardship.

(h)

Ensure access to
antimicrobial resistance data and research

The Director of the Antimicrobial
Resistance Office shall work with the Federal agencies represented on the
Antimicrobial Resistance Task Force to identify relevant data and formats, and
mechanisms for communicating such data to the Antimicrobial Resistance Office
and Antimicrobial Resistance Task Force and, in a manner consistent with
section 9 of the Strategies to Address Antimicrobial Resistance Act, with the
Public Health Antimicrobial Advisory Board and the public, including relevant
data obtained by the agencies through contracts with other organizations,
including—

(1)

use and clinical
outcomes data on patients receiving antimicrobial drugs for the treatment,
prevention, or diagnosis of infection or infectious diseases;

The Secretary of Health and Human Services, acting
through the Director of the Centers for Disease Control, shall establish at
least 10 Antimicrobial Resistance Surveillance and Laboratory Network sites,
building upon the intramural and extramural programs and laboratories of the
Centers for Disease Control and Prevention, to intensify, strengthen, and
expand the national capacity to—

(1)

monitor the
emergence and changes in the patterns of antimicrobial resistant
pathogens;

(2)

describe, confirm,
and as necessary facilitate a response to local or regional outbreaks of
resistant pathogens;

obtain isolates of
pathogens, and in particular, pathogens that show new or atypical patterns of
resistance adversely affecting public health;

(5)

study the
epidemiology of infections from such pathogens;

(6)

evaluate commonly
used antimicrobial susceptibility testing methods to improve the accuracy of
resistance testing and reporting; and

(7)

as necessary,
develop novel diagnostic tests capable of detecting new or emerging resistance
in pathogens.

(b)

Geographic
distribution

The sites established under subsection (a) shall be
geographically distributed across the United States.

(c)

Nonduplication
of current national capacity

The sites established under
subsection (a) may be based in academic centers, health departments, and
existing surveillance and laboratory sites.

5.

Clinical trials
network on antibacterial resistance

(a)

In
General

The Secretary, acting through the Director of the
National Institute of Allergy and Infectious Diseases, shall establish a
Clinical Trials Network on Antibacterial Resistance to enhance, strengthen, and
expand research on clinical science, antibacterial and diagnostic development,
and optimal usage strategies, and shall, at a minimum—

(1)

facilitate
research to better understand resistance mechanisms and how to prevent,
control, and treat resistant organisms;

examine patient
outcomes with currently available antimicrobial therapy and validate and
improve upon biomarkers and other surrogate end­points; and

(5)

study shorter
treatment duration and early cessation of antimicrobial therapy for treatment
efficacy and effect on development of resistance.

(b)

Leadership Group
for a Clinical Research Network on Antibacterial Resistance

The
Secretary, acting through the Director of the National Institute of Allergy and
Infectious Diseases, shall establish a Leadership Group for the Clinical
Research Network on Antibacterial Resistance described in subsection (a) to
develop and implement a comprehensive clinical research agenda to address
antibacterial resistance that takes into consideration the recommendations
contained in the Strategic Research Plan on Antimicrobial Resistance developed
in accordance with section 319E of the Public Health Service Act. The
Leadership Group shall provide support for the following components—

(1)

scientific
leadership and operations;

(2)

network
laboratories; and

(3)

statistical and
data management.

(c)

Appropriations

There
are authorized to be appropriated from the existing budget of the National
Institute of Allergy and Infectious Diseases, $100,000,000 annually for each of
fiscal years 2014 through 2020to carry out this section.

6.

Regional
prevention collaboratives

The
Secretary, acting through the Director of the Centers for Disease Control and
Prevention, shall work with State health departments to support regional
prevention collaboratives designed to interrupt and prevent the transmission of
significant antibiotic resistant pathogens being transmitted across health care
settings in a geographic region. Such regional prevention collaboratives shall
work to—

implement
evidence-based interventions to interrupt and prevent the transmission of such
pathogens; and

(3)

evaluate the
impact of such measures on hospital readmissions, transitions of care, rates of
health care associated infections, or any other relevant measures that
characterize the health or economic impact of the collaboratives.

7.

Prevention
Epicenters

To provide the
regional prevention collaboratives established under section 6 with tools,
strategies, and evidence-based interventions, the Director of the Centers for
Disease Control and Prevention may intensify and expand academic public health
partnerships through the work of the Prevention Epicenters Program of the
Centers of Disease Control and Prevention. The Centers for Disease Control and
Prevention and the epicenters participating in such program shall work with the
regional prevention collaboratives to—

(1)

evaluate new and
existing interventions to prevent or limit the emergence of antimicrobial
resistance throughout the geographic region of the collaboratives;

(2)

facilitate public
health research on the prevention and control of resistant organisms;
and

(3)

assess the
feasibility, cost-effectiveness, and appropriateness of surveillance and
prevention programs in differing health care and institutional settings.

8.

Continuation of
current programs

Subsection
(j) of section 319E of the Public Health Service Act (42 U.S.C. 247d–5), as
redesignated by section 3(6), is amended by inserting and for each of
the fiscal years 2014 through 2018 after 2006.

9.

Protection of
confidential and national security information

Except as otherwise required by law, this
Act (and the amendments made by this Act) shall not permit public disclosure of
trade secrets, confidential commercial information, or material inconsistent
with national security that is obtained by any person under this Act (or
amendments made by this Act).